Pre and Post Treatment Metabolomic Analysis of Leukemia: A Translational Clinical Trial of the Brown Cancer Center

NCT02193100 | Withdrawn DMC

• 1 other identifier: BCC-BMT-13 Leuk Metabolomics
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

To characterize the metabolism of glucose by the leukemic cells in patients with leukemia before and after initial chemotherapy. To compare the metabolism of glucose by leukocytes in healthy volunteers and leukemic cells in leukemic patients.

Conditions

Leukemia

Outcome Measures

Primary Outcomes (1)

• Metabolic characteristics of leukemic cells from blood and urine samples using nuclear magnetic resonance spectroscopy (NMR)

  Blood and urine samples will be taken before and after chemotherapy treatment for up to 6 months post treatment and analyzed for metabolic substances using nuclear magnetic resonance (NMR) spectroscopy with intergraded hyphenated mass spectrometry.

  Baseline up to 6 months post treatment

Study Arms (2)

13C-glucose

experimental (13C-glucose)

No glucose

control (no glucose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Leukemia Subjects-clinically diagnosed or histologically diagnosed leukemia Healthy Subjects-no record of diagnosed cancer or hematologic disorders

You may qualify if:

• Each of the criteria in the following section must be met in order for a patient to be eligible for enrollment.
• Only patients with clinically diagnosed or histologically diagnosed leukemia will be eligible to participate in this non-therapeutic study.
• All patients must have measurable quantities of leukemic blasts on peripheral blood detected with a CBC.
• No history of diabetes for the experimental group or the control group.
• Patients with known hepatitis C or HIV (AIDS) are excluded.
• Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.
• Subjects must have no known prior history of cancer or malignant blood disorders. -Where possible, follow up will be carried out to verify that no cancer has developed since the blood collection. This will be done by a phone call performed one month from sample to ask if new medical conditions have arisen.
• Subjects must have WBC, RBC, and platelet counts within normal range on CBC.
• Subjects with known hepatitis C or HIV (AIDS) are excluded.
• No history of Diabetes
• At least 30 years of age
• Preferably be fasting for 12 hours (minimum 8 hours) prior to enrollment
• Patients must be informed of the investigational nature of this study and sign and give written informed consent in accordance with institutional and federal guidelines.

You may not qualify if:

• None listed in protocol

Sponsors & Collaborators

• University of Louisville: lead
• James Graham Brown Cancer Center: collaborator

Study Sites (1)

James Graham Brown Cancer Center-University of Louisville

Louisville, Kentucky, 40202, United States

Location

MeSH Terms

Conditions

Leukemia

Condition Hierarchy (Ancestors)

Neoplasms by Histologic Type; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 12, 2014
• First Posted: July 17, 2014
• Study Start: August 1, 2014
• Primary Completion: June 1, 2018
• Study Completion: June 1, 2019
• Last Updated: December 29, 2017

Record last verified: 2016-01

Locations

US (1)